Sodium Channel Splicing in Heart Failure Trial (SOCS-HEFT) Prospective Study
Status unconfirmed · Not applicable
Conditions studied: Death, Sudden, Cardiac
In brief
Congestive heart failure (CHF) represents a major health care concern in the United States. Currently, risk stratification of sudden cardiac death and the need for implantable cardioverter-defibrillator (ICD) placement are essentially dependent upon assessment of left ventricular ejection fraction (LVEF). Nevertheless, the predictive value of LVEF is suboptimal, alternative testing for risk assessment for the development of sudden cardiac death in the heart failure population is desirable. At the genome level, the investigator has focused on the role of SCN5A gene mutations in arrhythmogenesis. Lymphocyte SCN5A mRNA processing may serve as a surrogate marker to assess SCN5A function at the cardiac level and may correlated with arrhythmic risk in high risk populations. This study will determine if SCN5A variant levels are predictive of appropriate ICD therapies in patients with a newly implanted ICD.
Key facts
- Study ID
- NCT02738749
- Run by
- Rhode Island Hospital
- People needed
- 450
- Starts
- 2014-06-01
- Expected to finish
- 2020-07-01
- Last updated by the study team
- 2017-04-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients must be greater than 18 years of age.
- All patients must be able to give informed consent.
- Patients must receive an ICD within 10 days for primary prevention.
You may not qualify if…
- Patients less than 18 years of age.
- History of congenital heart disease.
- History of congenital electrophysiological disorders like the long-QT syndrome or Brugada disease.
- Patients have an ICD implanted for secondary prevention.
- Patients taking immunosuppressive medications, have chronic infection, or have an acute or chronic inflammatory illness that might alter white cell mRNA expression.
- Patients with any illness expected to result in death within 18 months of enrollment.
- Patients with white blood cell dyscrasia or cancers.
- Patients with end-stage renal disease (ESRD) on hemodialysis or peritoneal dialysis
- Current illicit drug use.
- Inability to give informed consent.
Where it is running
- Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
Full record on ClinicalTrials.gov
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